Blog

From FDA’s approval of the first cannabis-based product in the U.S., to the classification of two Apple Watch apps and changes in the Agency’s submission requirements related to Sponsor meetings, it’s safe to say 2018 was a busy year for all of us. As we look back on all that has happened throughout the year, […] READ MORE... ▸

Over the past 20 years, the traditional approach to drug development has expanded to include the outsourcing of a range of testing and manufacturing functions. As a part of their long-term strategic view, successful Sponsors understand the need to leverage the knowledge and resources that external specialist organizations bring to the table. Sponsors of every […] READ MORE... ▸

Facing several regulatory challenges related to the review of abbreviated new drug applications (ANDAs), Congress first enacted the Generic Drug User Fee Amendment (GDUFA I) in 2012. After negotiations between the FDA and industry representatives, and with input from public stakeholders, Congress mapped out the concept that generic drug sponsors would pay a user fee […] READ MORE... ▸

The drug development process is long and expensive. You are doing yourself and your product a huge advantage if you enter and go through the process with a well-researched plan. When planning your FDA submission, you need to “play the long game.” This means that you must have more than just set a goal. It’s […] READ MORE... ▸

Sponsors may transfer any or all of their many tasks and obligations relating to clinical trials to Contract Research Organizations (CROs). This ability to delegate through a Transfer of Regulatory Obligations (TORO) brings with it a range of advantages to the Sponsor. However, because the Sponsor is ultimately responsible, they must be aware of the […] READ MORE... ▸

Before using a significant risk medical device in a clinical study, sponsors must first obtain FDA approval. Frequently, the request for an investigational device exemption (IDE) is disapproved, and the impact of this disapproval can be significant, as sponsors have invested a great deal of time and resources into development of the device before they […] READ MORE... ▸

Remember the last time you were pulled over by the police? Maybe you had a tail light out. Perhaps you were speeding. You may have believed that you had done nothing wrong. Regardless of the specific situation, you probably panicked a little. It’s human nature to panic when the government tells you that you’ve done […] READ MORE... ▸

On Tuesday, July 17th, FDA released a new draft guidance entitled “Innovative Approaches for Nonprescription Drug Products.” The guidance discusses two different approaches for making nonprescription drugs more accessible to consumers. Regulatory Pathways for Nonprescription Drugs There are currently two different pathways for nonprescription drugs: Over-the-Counter Drug Review (OTC Monograph Process) New Drug Application (NDA) […] READ MORE... ▸

Generic drugs are immensely important to the U.S. healthcare system. These drugs account for 89% of the prescriptions dispensed in the United States. And, over the last decade, generic drugs have saved consumers more than $1.67 trillion. In 2017, the FDA’s Office of Generic Drugs approved or tentatively approved 1,027 abbreviated new drug applications (ANDAs), […] READ MORE... ▸

By the time the drug development process gets to Phase 3, it seems reasonable to assume that the chance of failure is relatively low. After all, the entire early-development process is at least partially designed to reduce the risk of failure of the longer and more expensive clinical trials. The knowledge gained from the data […] READ MORE... ▸